Management of the regulatory process for medical devices and pharmaceuticals, including obtaining FDA approval for new products and ensuring ongoing compliance with regulations.
Regulatory environment: Understanding the regulatory landscape and the different entities involved in the regulation of biomedical devices and products.
Medical device classification: Learning about the classification of medical devices based on their risk level and the different regulatory requirements associated with each classification.
Clinical trials: Understanding the process of conducting clinical trials for medical devices and the regulatory requirements associated with it, including ethical considerations.
Quality management systems: Learning about quality management systems and the different standards that are relevant in this area, such as ISO 13485.
Risk management: Understanding the concept of risk management and how it applies to biomedical devices, including the identification, assessment, and mitigation of risks.
Post-market surveillance: Learning about the different aspects of post-market surveillance, including adverse event reporting, post-market studies, and signal detection.
Labeling and packaging: Understanding the regulatory requirements for labeling and packaging of biomedical devices, including symbols, warnings, and instructions.
Post-market changes: Learning about the regulatory requirements associated with post-market changes to biomedical devices, including design changes, manufacturing changes, and labeling changes.
Combination products: Understanding the regulatory requirements for combination products, which are products that combine drugs, devices, or biologicals.
International regulatory requirements: Learning about the regulatory requirements for biomedical devices in different countries and regions, including the EU, Canada, and Japan.
Regulatory Affairs Associate: Assists in preparing regulatory documents and communicating with regulatory agencies.
Regulatory Compliance Specialist: Ensures that the products are meeting regulatory guidelines and laws.
Medical Device Regulatory Specialist: Manages the regulatory compliance of medical devices.
Quality Assurance Specialist: Ensures the quality and safety of the product.
Regulatory Affairs Manager: Manages a team responsible for regulatory compliance and documentation.
Clinical Research Associate: Conducts studies to gain regulatory approval for drugs, medical devices, and other products.
Senior Regulatory Affairs Specialist: Provides leadership for a regulatory affairs team.
Clinical Trial Manager: Responsible for the planning, implementation, and monitoring of clinical trials.
Regulatory Affairs Consultant: Provides guidance and advice to companies regarding regulatory compliance.
Labeling Specialist: Ensures that product labels are accurate and comply with regulatory guidelines.